510(k) Report

FDA product code · General and plastic surgery

Stapler, Skin

QQSClass I21 CFR 878.4740510(k) exempt0 decisions0 recalls

FDA lists QQS as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of QQS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QQS

FDA has decided no QQS device since 2007.

Median 510(k) review, days · QQS

Too few QQS 510(k)s in any year since 2007 to give a median.

Recalls per year · QQS

No recall names QQS since 2007.

Adverse event reports per year · QQS

513in 2025

2022: 5162023: 1,2932024: 1,2752025: 513
2007high 1,293 (2023) · low 0 (2007)2025

MAUDE reports naming product code QQS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—0516
20230—01,293
20240—01,275
20250—0513
20260—0—
FIG. 1 — QQS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QQS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 878.4740.

GAG Stapler, Surgical